(119 days)
No
The device description and performance studies focus on the mechanical and material properties of a pen needle, with no mention of AI or ML capabilities.
No
The description clearly states this product is a pen needle, which is a delivery mechanism for fluids. It does not treat or diagnose a disease or condition itself, which are characteristics of a therapeutic device.
No.
The device is described as a pen needle for the "hypodermic injection of fluids into the body" and for the "administration of prescribed fluids." This indicates it is used for delivering substances, not for diagnosing conditions.
No
The device description clearly describes a physical pen needle, which is a hardware component. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "hypodermic injection of fluids into the body." This describes a device used on the body for delivering substances, not for testing samples from the body to diagnose conditions.
- Device Description: The description details a needle used with a pen-injector to deliver fluids. It focuses on the physical mechanism of injection and the sterile nature of the needle. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring specific substances (analytes) in samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
This device is a medical device used for drug delivery, specifically through injection. It falls under the category of devices used for administering substances to a patient, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The Clickfine pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen.
Product codes
FMI
Device Description
The Yosomed Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needles are used by peeling back the peel tab and snapping the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the pen-injector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the insulin is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Y psomed has performed the relevant assessments specified in the following international and internal standards and protocols and confirmed compliance of the modified devices and equivalence to the predicate devices.
The Clickfine Pen Needles have met the requirements of the relevant sections of the following standards:
- ISO 11608-2:2000 Pen-injectors for medical use -- Part 2: Needles Requirements . and test methods
- ISO 9626:1991/Amd.1:2001 Stainless steel needle tubing for the manufacture of . medical devices
- ISO 7864:1993 Sterile hypodermic needles for single use .
- ISO 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation . and testing
- . Puncture resistance of outer cap - Equivalent to Unmodified Device
- Seal Integrity of Sterile barrier Equivalent to Unmodified Device ●
The verifications have shown evidence that the Clickfine Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Summary of Safety and Effectiveness
NOV 2 3 2010
"510(K) SUMMARY"
| Submitted By/
| Contact Person: | Dr. Manfred Mäder |
|---|---|
| Senior Vice President | |
| Quality Management & Regulatory Affairs | |
| Ypsomed AG | |
| Brunnmattstrasse 6 | |
| CH - 3401 Burgdorf | |
| Switzerland | |
| Tel. 0041-344244111 | |
| Fax 0041-344244122 | |
| E-mail: manfred.maeder@ypsomed.com |
Date Prepared: August 20, 2010
- Clickfine Pen Needle Trade/Proprietary Name: 7.1
- 7.2 Common/Usual Name:
Injection Pen Needle
-
7.3 Classification Name:
Hypodermic single lumen needle -
7.4 Classification: FDA has classified Hypodermic single lumen needles in Class II. Final Order was published in the Federal Register on October 21, 1980 after review by the General Hospital and Personal Use Devices Classification Panel.
Panel: 80 Procode: FMI -
7.5 Purpose of Submission: To establish the substantial equivalence of the modified Y psomed Clickfine Pen Needles to the Disetronic Penfine Insulin Injection Pen Needles.
Substantial Equivalence: The Ypsomed Clickfine Pen Needles are substantially equivalent to the Disetronic Penfine Injection Pen Needles (K994197). The equivalence is supported by the attached documentation. -
7.6 Device Description
The Yosomed Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needles are used by peeling back the peel tab and snapping the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the pen-injector. The outer protective cap is then removed. The inner protective cap will remain over
1
the needle until the insulin is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.
- 7.7 Intended Use
The intended use of the modified device remains the same as the predicate device (Disetronic Penfine Injection Pen Needles, K994197):
The Ypsomed Clickfine Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injection pen.
7.8 Technological Characteristics The technological characteristics have not changed.
- 7.9 Performance and Safety Data
Y psomed has performed the relevant assessments specified in the following international and internal standards and protocols and confirmed compliance of the modified devices and equivalence to the predicate devices.
The Clickfine Pen Needles have met the requirements of the relevant sections of the following standards:
- ISO 11608-2:2000 Pen-injectors for medical use -- Part 2: Needles Requirements . and test methods
- ISO 9626:1991/Amd.1:2001 Stainless steel needle tubing for the manufacture of . medical devices
- ISO 7864:1993 Sterile hypodermic needles for single use .
- ISO 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation . and testing
- . Puncture resistance of outer cap - Equivalent to Unmodified Device
- Seal Integrity of Sterile barrier Equivalent to Unmodified Device ●
The verifications have shown evidence that the Clickfine Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product.
7.10 Conclusion
Ypsomed AG concludes based on the information presented that the modified product is substantially equivalent to the current product legally marketed in the USA.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Manfred Mader Senior Vice President Quality Management & Regulatory Affairs YPSOMED AG Brunnmattstrasse 6 Burgdorf Switzerland CH-3401
NOV 2 3 2010
Re: K102108
Trade/Device Name: Clickfine Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: October 27, 2010 Received: November 4, 2010
Dear Mr. Mader:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2- Mr. Mader
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely, yours,
Hiens J. Roberts
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Indications for Use
NOV 2 3 2010
510(k) Number (if known):
Device Name:
Indications For Use:
Clickfine Pen Needle
The Clickfine pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen.
.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ion (ODE)
Ald C. Chape 11/22/20
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102108